The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

12326–12350 of 21617

  • ModerateFDA (Devices)·Z-2646-2017·2017-07-05

    Onkos Surgical Recalls ELEOS Limb Salvage System Segmental Stem Due to Labeling Error

    Onkos Surgical is recalling four units of the ELEOS Limb Salvage System Segmental Stem because the device collar size was incorrectly labeled as 25 mm instead of 32 mm.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2632-2017·2017-07-05

    3M Ranger Pressure Infusor Recalled for Pressure Specification Deviation

    3M is recalling one Ranger Pressure Infusor, Model 145, because it produced pressure slightly below manufacturing specifications.

    Product
    3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2641-2017·2017-07-05

    Merge Healthcare Recalls Masimo SPO2 Sensors for Display Failure

    Merge Healthcare is recalling Masimo SPO2 ear clip sensors because cables may stop displaying SpO2 readings, causing slight delays in patient care.

    Product
    Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2644-2017·2017-07-05

    Exactech Novation Calcar Planer Guide Tip Recalled for Labeling Clarification

    Exactech is recalling 477 Novation Calcar Planer Guide Tips to update labeling with a caution about instrument breakage.

    Product
    Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0924-2017·2017-07-05

    Apothecary by Design Recalls Progesterone Injection Vials Due to Closure Defect

    Apothecary by Design is recalling 25 vials of Progesterone Injection in Olive Oil due to a manufacturing defect where metal closures may adhere to rubber stoppers, potentially compromising container integrity.

    Product
    Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2407-2017·2017-07-05

    ProSupps Recalls Dr. Jekyll V2 Green Apple International Due to Mislabeling

    ProSupps USA LLC is recalling 3,045 units of Dr. Jekyll V2 Green Apple International because the product is potentially mislabeled and contains the non-dietary ingredient Picamilon.

    Product
    Dr. Jekyll V2 Green Apple International
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2401-2017·2017-07-05

    ProSupps Recalls Mr. Hyde Fruit Punch for Undeclared Picamilon Ingredient

    ProSupps USA LLC is recalling specific Mr. Hyde Fruit Punch products because they are potentially mislabeled and contain the non-dietary ingredient Picamilon.

    Product
    Mr. Hyde, Fruit Punch, 30 servings; Mr. Hyde Fruit Punch (V2); Mr. Hyde 30 INT'L Fruit Punch; Mr. Hyde Fruit Punch RTD; Mr. Hyde V2 domestic Fruit Punch
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2638-2017·2017-07-05

    Beckman Coulter Access System-GI Monitor Recalled for Biotin Interference

    Beckman Coulter is recalling Access System-GI Monitor (CA19-9) kits because they are susceptible to biotin interference, which may affect test results.

    Product
    Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2408-2017·2017-07-05

    ProSupps Recalls Dr. Jekyll V2 Orange Burst for Undeclared Ingredient

    ProSupps USA LLC is recalling 698 units of Dr. Jekyll V2 Orange Burst because the product is potentially mislabeled and contains the non-dietary ingredient Picamilon.

    Product
    Dr. Jekyll V2 Orange Burst domestic
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2648-2017·2017-07-05

    Onkos Surgical Recalls Mislabelled Limb Salvage System Segmental Stem

    Onkos Surgical, Inc. is recalling four units of the Eleos Limb Salvage System Segmental Stem due to incorrect collar size labeling.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2613-2017·2017-06-28

    Abbott Recalls ARCHITECT SHBG Reagent Due to Specimen Tube Interference

    Abbott Laboratories is recalling 7,981 kits of ARCHITECT SHBG Reagent because using Potassium EDTA specimen tubes may cause falsely decreased test results.

    Product
    ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2609-2017·2017-06-28

    Siemens Ferritin Cartridge Recalled for Incorrect Biotin Interference Labeling

    Siemens Healthcare Diagnostics is recalling Dimension Vista Ferritin reagent cartridges because the instructions for use contain incorrect units and levels for biotin interference.

    Product
    Dimension Vista Ferritin (FERR) Flex reagent cartridge
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2608-2017·2017-06-28

    Siemens Dimension Vista Estradiol Reagent Cartridge Recall for Labeling Error

    Siemens Healthcare Diagnostics is recalling Dimension Vista Estradiol reagent cartridges because the instructions for use contain incorrect biotin interference units.

    Product
    Dimension Vista Estradiol (E2) Flex reagent cartridge
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0921-2017·2017-06-28

    Lucid Pharma Recalls Venlafaxine Hydrochloride Extended-Release Capsules Due to Melted Capsules

    Lucid Pharma LLC is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, because pharmacists reported bottles containing melted capsules.

    Product
    Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottles (NDC 52343-132-90), Rx only, Distributed by: Lucid Pharma LLC, 2 Tower Center Blvd, Suite-1101-B, East Brunswick, NJ 08816 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2611-2017·2017-06-28

    Siemens Dimension Vista TSH Reagent Cartridge Recall for Incorrect Biotin Units

    Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions for use list incorrect units and interference levels for biotin.

    Product
    Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2612-2017·2017-06-28

    Z-Medica Recalls QuikClot TraumaPad Due to Packaging Sterility Concerns

    Z-Medica is recalling 2,910 units of QuikClot TraumaPad hemostatic dressings because packaging breaches may compromise sterility.

    Product
    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2601-2017·2017-06-28

    Merge OrthoPACS software recalled due to data propagation failures

    Merge Healthcare is recalling specific versions of Merge OrthoPACS software because studies may fail to transfer or import correctly between servers.

    Product
    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2610-2017·2017-06-28

    Siemens Dimension Vista Prolactin Reagent Cartridge Recall for Labeling Error

    Siemens Healthcare Diagnostics is recalling Dimension Vista Prolactin reagent cartridges because the instructions for use contain incorrect biotin interference data.

    Product
    Dimension Vista Prolactin (PRL) Flex reagent cartridge
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2620-2017·2017-06-28

    Merge OrthoPACS Software Recalled for Annotation Display Error

    Merge Healthcare is recalling Merge OrthoPACS software versions 6.6, 6.6.1, and 6.6.2 because prior studies may fail to display annotations.

    Product
    Merge OrthoPACS software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2578-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures

    Zimmer Biomet is recalling 9,867 sterile porous femoral stems because packaging design verification tests failed. The recall covers units distributed worldwide.

    Product
    Por fullct fem st 16x200mm, Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2595-2017·2017-06-21

    Zimmer Biomet Recalls R-F IM Nails Due to Packaging Design Failures

    Zimmer Biomet is recalling 3,856 sterile-packaged R-F IM Nails because packaging design verification tests failed. The action covers units distributed domestically and internationally.

    Product
    R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-2325-2017·2017-06-21

    Pentax Video Cytoscopes Recalled for Loose Suction Arms

    Pentax of America Inc. is recalling Video Cytoscopes to correct loose suction arms. This action retrospectively documents corrections made in 2010-2011.

    Product
    Video Cytoscopes
    Category
    Medical Device
    Distribution
    Distributed nationwide